Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002026

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: May 1990

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
Official Title ^ICMJE	Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
Brief Summary	To evaluate the efficacy of oral acyclovir for the treatment and suppression of Epstein-Barr virus (EBV) related hairy leukoplakia (HL). To determine the long-term safety of acyclovir in the AIDS-related complex (ARC) patient with HL. To monitor the progression of HIV disease in the HL patient and compare to existing historical control data.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Leukoplakia, Hairy HIV Infections
Intervention ^ICMJE	Drug: Acyclovir
Study Arm (s)	Not Provided
Publications *	Herbst JS, Morgan J, Raab-Traub N, Resnick L. Comparison of the efficacy of surgery and acyclovir therapy in oral hairy leukoplakia. J Am Acad Dermatol. 1989 Oct;21(4 Pt 1):753-6.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria Concurrent Medication: Allowed: Topical antifungal therapy. Patient must have: Newly diagnosed clinical and histological hairy leukoplakia. Positive HIV antibody by licensed ELISA or Western blot. Exclusion Criteria Co-existing Condition: Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded. Concurrent Medication: Excluded within 2 weeks of study entry: Systemic antifungal treatment. Excluded within 6 weeks of study entry: Immunomodulators. Systemic antiviral treatment. Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded. Prior Medication: Excluded within 2 weeks of study entry: Systemic antifungal. Excluded within 6 weeks of study entry: Immunomodulators. Systemic antiviral treatment. Excluded within 8 weeks of study entry: Zidovudine (AZT) or other antiretroviral therapy.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002026
Other Study ID Numbers ^ICMJE	033A, 179
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1990
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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